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Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy

NCT01500642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-01-05

No results posted yet for this study

Summary

The dose and the mode of administration of sublingual therapy remain open questions to determine the efficacy and safety of this desensitization therapy, the main purpose of this study is to evaluate if different routes of administration (oral-vestibular vs. sublingual) and a maximum dose of allergen administered are able to determine a different effect or a different incidence of side effects of the therapy in a group of patients with rhinoconjunctivitis and/or asthma due to ragweed

Conditions

  • Pollen Allergy

Interventions

BIOLOGICAL

Slit One

slit one sublingual immunotherapy 200 stu

BIOLOGICAL

Slit One

slit one vestibular immunotherapy 200 stu

BIOLOGICAL

Slit One ragweed

slit one 400 stu dose ragweed (sublingual doubled immunotherapy)

Sponsors & Collaborators

  • ALK-Abelló A/S

    collaborator INDUSTRY

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • enrico iemoli, phd · luigi sacco hospital milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500642 on ClinicalTrials.gov